CAMBRIDGE, Mass.--(BUSINESS WIRE)--AVEO Oncology (NASDAQ:AVEO) today announced the completion of a
pre-planned futility analysis of the Phase 3 TIVO-3 trial, the Company’s
randomized, controlled, multi-center, open-label study to compare FOTIVDA®
(tivozanib) to sorafenib in subjects with refractory advanced renal cell
carcinoma (RCC). Based on the results of the futility analysis, which
was reviewed by an independent statistician, the study will continue as
planned without modification. This analysis did not allow for early
stopping due to efficacy to assure adequate follow-up for the key
secondary endpoint of overall survival. The pre-planned futility
analysis was triggered by the reporting of 128 progression events in
early August. Additional events were recorded as part of the data
management process leading into the futility analysis, resulting in a
revised data cut-off date for the analysis of May 29. The Company
continues to expect the TIVO-3 to read out in the first quarter of 2018.

The TIVO-3 trial, together with the previously completed TIVO-1 trial of
tivozanib in the first line treatment of RCC, is designed to support
regulatory approval of tivozanib in the U.S. as a first and third line
treatment for RCC.

“The treatment of advanced renal cell cancer is undergoing rapid change,
with immunotherapy and combination regimens delivering improved outcomes
for patients and shaping a new treatment paradigm,” said Michael Bailey,
president and chief executive officer of AVEO. “We believe our tivozanib
clinical strategy positions us well in this evolving landscape, with the
TIVO-3 study on track to provide the first post-immunotherapy pivotal
datasets for a VEGF-TKI, and the TiNivo study providing early and
encouraging combination data. We look forward to readout of the TIVO-3
trial in the first quarter of 2018. We also look forward to presenting
Phase 1 results from the Phase 1/2 TiNivo study of tivozanib in
combination with OPDIVO® at a medical conference this fall,
and to leveraging tivozanib’s unique safety and efficacy profile in
future potential therapy combinations.”

The TIVO-3 trial was designed to enroll patients with recurrent RCC who
have failed at least two prior regimens, including VEGFR-TKI therapy
(other than sorafenib). Eligible patients may also have received
checkpoint inhibitor therapy in earlier lines of treatment. Patients are
randomized 1:1 to receive either tivozanib or sorafenib, with no
crossover between arms. The primary endpoint of the study is progression
free survival. Secondary endpoints include overall survival, overall
response rate, and safety and tolerability.

The TiNivo trial is a Phase 1/2 study of tivozanib in combination with
Bristol-Myers Squibb’s OPDIVO® (nivolumab), an immune
checkpoint, or PD-1, inhibitor, for the treatment of RCC. The TiNivo
trial is being led by the Institut Gustave Roussy in Paris under the
direction of Bernard Escudier, MD, Chairman of the Genitourinary
Oncology Committee. The trial advanced into the Phase 2 expansion
portion following successful completion of the Phase 1 dose escalation
portion. The combination was well tolerated to the full dose and
schedule of single agent tivozanib, with no dose limiting toxicities.
The expansion portion of the trial is expected to enroll an additional
20 subjects. Phase 1 results from the ongoing study have been submitted
for presentation at a scientific meeting taking place in the fourth
quarter.

About Tivozanib (FOTIVDA®)

Tivozanib (FOTIVDA®) is an oral, once-daily, vascular
endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)
discovered by Kyowa Hakko Kirin and approved for the treatment of adult
patients with advanced renal cell carcinoma in the European Union plus
Norway and Iceland. It is a potent, selective and long half-life
inhibitor of all three VEGF receptors and is designed to optimize VEGF
blockade while minimizing off-target toxicities, potentially resulting
in improved efficacy and minimal dose modifications. Tivozanib has been
investigated in several tumors types, including renal cell, colorectal
and breast cancers.

About AVEO

AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to
advancing a broad portfolio of targeted therapeutics for oncology and
other areas of unmet medical need. The Company is focused on seeking to
develop and commercialize its lead candidate tivozanib, a potent,
selective, long half-life inhibitor of vascular endothelial growth
factor 1, 2 and 3 receptors, in North America as a treatment for renal
cell carcinoma and other cancers. AVEO is leveraging multiple
partnerships aimed at developing and commercializing tivozanib in
oncology indications outside of North America, and at progressing its
pipeline of novel therapeutic candidates in cancer and cachexia (wasting
syndrome). Tivozanib (FOTIVDA®) is approved by the European Commission
for the treatment of adult patients with advanced renal cell carcinoma
(RCC) in the European Union plus Norway and Iceland. For more
information, please visit the company’s website at www.aveooncology.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO that
involve substantial risks and uncertainties. All statements, other than
statements of historical fact, contained in this press release are
forward-looking statements. The words “anticipate,” “believe,” “expect,”
“intend,” “may,” “plan,” “potential,” “could,” “should,” “would,”
“seek,” “look forward,” “advance,” “goal,” “strategy,” or the negative
of these terms or other similar expressions, are intended to identify
forward-looking statements, although not all forward-looking statements
contain these identifying words. These forward-looking statements
include, among others, statements about: clinical, regulatory and
commercial plans of AVEO and its partner EUSA Pharma to progress the
development of FOTIVDA® (tivozanib); the expected timeline for reporting
data from TIVO-3; the role and expected benefits of tivozanib and other
TKIs on a stand-alone basis, or in combination with or following
immunotherapy; the expected enrollment of the TiNivo trial and
presentation of TiNivo results; expectations about the potential for
additional payments by EUSA Pharma; the value of AVEO's partnerships in
advancing its pipeline; and AVEO’s strategy, prospects, plans and
objectives, including as they pertain specifically to tivozanib. AVEO
has based its expectations and estimates on assumptions that may prove
to be incorrect. As a result, readers are cautioned not to place undue
reliance on these expectations and estimates. Actual results or events
could differ materially from the plans, intentions and expectations
disclosed in the forward-looking statements that AVEO makes due to a
number of important factors, including risks relating to AVEO’s ability
to enter into and maintain its third party collaboration agreements, and
its ability, and the ability of its licensees and other partners, to
achieve development and commercialization objectives under these
arrangements; AVEO’s ability, and the ability of its licensees, to
demonstrate to the satisfaction of applicable regulatory agencies the
safety, efficacy and clinically meaningful benefit of AVEO’s product
candidates, including tivozanib. AVEO faces other risks relating to its
business as well, including risks relating to its ability to
successfully enroll and complete clinical trials, including the TIVO-3
and TiNivo studies; AVEO’s ability to achieve and maintain compliance
with all regulatory requirements applicable to its product candidates;
AVEO’s ability to obtain and maintain adequate protection for
intellectual property rights relating to its product candidates and
technologies; developments, expenses and outcomes related to AVEO’s
ongoing shareholder litigation; AVEO’s ability to successfully implement
its strategic plans; AVEO’s ability to raise the substantial additional
funds required to achieve its goals, including those goals pertaining to
the development and commercialization of tivozanib; unplanned capital
requirements; adverse general economic and industry conditions;
competitive factors; and those risks discussed in the section titled
“Risk Factors” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations—Liquidity and Capital Resources”
included in AVEO’s Annual Report on Form 10-K for the year ended
December 31, 2016, its quarterly reports on Form 10-Q and in other
filings that AVEO may make with the SEC in the future. The
forward-looking statements in this press release represent AVEO’s views
as of the date of this press release. AVEO anticipates that subsequent
events and developments may cause its views to change. While AVEO may
elect to update these forward-looking statements at some point in the
future, it specifically disclaims any obligation to do so. You should,
therefore, not rely on these forward-looking statements as representing
AVEO's views as of any date other than the date of this press release.